作者：张奇芳1, 范继来2, 鞠薇薇1, 吕慧明1, 刘伟2, 李晓旭2, 曲艳玲2
作者单位：1. 辽东学院医学院，辽宁 丹东 118003;
2. 丹东百特仪器有限公司研发中心，辽宁 丹东 118009
关键词：颗粒计数器;光阻法;散射法;医药分析;注射液;脂肪乳
摘要：
通过对一种高精度的光学法颗粒计数器原理、研制、验证和应用过程的描述，展示一种新的光阻法与散射法相结合的测量方式，提升测量范围和精度，尤其是设计厚度仅为20 μm的片状光源，提升计数效率。此外，在信号处理上采用了平滑比较器的数学模型，既能有效过滤噪声信号，又能精确提取有效信号的数量与高度，准确测量颗粒数量与粒径，95%重合误差极限为45000 个 / mL，对1.6、4.8、8、16、32 μm五种标准粒径物质混合测试，可以得到准确的五峰分布。对氯化钠注射液和脂肪乳进行测量验证，三个厂家的0.9%氯化钠注射液的不溶性微粒含量达到药典要求，三种脂肪乳样品，G1和G2的PFAT5<0.05%，符合药典要求，合格；而样品G3的PFAT5>0.05%，不符合药典要求，不合格。以上表明该仪器在医药领域具有良好的应用前景。
Development of a new optical particle counter and its application in pharmaceutical analysis
ZHANG Qifang1, FAN Jilai2, JU Weiwei1, Lü Huiming1, LIU Wei2, LI Xiaoxu2, QU Yanling2
1. Medical School，Eastern Liaoning University, Dandong 118003, China;
2. R＆D center，Dandong Bettersize Instruments Co., Ltd., Dandong 118009, China
Abstract: A high-precision optical particle counter was introduced, which combines light obscuration and light scattering technologies, improving the measurement range and measurement precision of the apparatus. Cylindrical lens and roof prism characterize the design of the light source, resulting in a square-shaped laser beam whose thickness is only 20μm. The particle counting efficiency is therefore improved. The utilization of a mathematical model of smoothing comparator in terms of pulse signal extraction leads to not only effective signal noise filtration but also accurate extraction of the pulse number and intensity, and accurate calculation of the number and size of particles. The 95 % coincidence error limit is 45000 / mL,and the accurate five-peak distribution can be obtained by mixing the five standard particle size materials of 1.6,4.8,8,16,32 μm.Sodium chloride injection and fat emulsion were measured and verified. The content of insoluble particles in 0.9% sodium chloride injection from three manufacturers meets the requirements of the pharmacopoeia.In the three fat emulsion samples, the PFAT5 of G1 and G2 <0.05%, which meets the requirements of the pharmacopoeia,qualified; However, the PFAT5 of G3 >0.05%, which does not meet the requirements of the pharmacopoeia,unqualified.The above shows that the apparatus has a good application prospect in the medical analysis domain.
Keywords: particle counter;light obscuration method;light scattering method;pharmaceutical analysis;injection;fat emulsion
2024, 50(5):122-129 收稿日期: 2022-11-18;收到修改稿日期: 2023-01-09
基金项目:
作者简介: 张奇芳(1979-),女,辽宁阜新市人,讲师,硕士,主要从事医学、基础医学教学及临床实验工作。
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